TAMOXIFENE CINFA 10 mg TABLETS
How to use TAMOXIFENE CINFA 10 mg TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Tamoxifen Cinfa 10 mg Tablets EFG
Tamoxifen Citrate
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the Package Leaflet
- What is Tamoxifen Cinfa and what is it used for
- What you need to know before taking Tamoxifen Cinfa
- How to take Tamoxifen Cinfa
- Possible side effects
- Storage of Tamoxifen Cinfa
- Contents of the pack and further information
1. What is Tamoxifen Cinfa and what is it used for
Tamoxifen Cinfa belongs to a group of medicines called anti-oestrogens.
Tamoxifen Cinfa is indicated for certain breast conditions.
2. What you need to know before taking Tamoxifen Cinfa
Do not take Tamoxifen Cinfa
- Tamoxifen should not be given to children and adolescents, as its safety and efficacy in this age group have not been established.
- These tablets are for your use only and should not be given to anyone else.
- If you are allergic to tamoxifen or any of the other ingredients of this medicine (listed in section 6).
- If you are pregnant.
Warnings and Precautions
Consult your doctor or pharmacist before starting to take Tamoxifen Cinfa.
- Never take any other medicine without consulting your doctor, as some combinations should be avoided.
- Consult your doctor about the contraceptive methods you should use, as some may be affected by this medicine.
- It is essential that you inform your doctor immediately if you experience any unusual vaginal bleeding or other gynaecological symptoms (such as pain or pressure in the pelvic area) during treatment with tamoxifen or at any time afterwards. This is because certain changes can occur inside the uterus (endometrium), some of which can be serious.
- Concomitant administration with the following medicines should be avoided, as it cannot be excluded that the effects of tamoxifen may be reduced: paroxetine, fluoxetine (e.g. antidepressants), bupropion (antidepressant or used to quit smoking), quinidine (used to treat cardiac arrhythmia), and cinacalcet (for the treatment of parathyroid disorders).
- Before starting treatment with this medicine, it is essential that you inform your doctor if you or any member of your family has a history of blood clots or any known hereditary condition that may increase the risk of forming these clots.
- If you are admitted to hospital, inform the medical staff that you are taking Tamoxifen Cinfa.
- Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with tamoxifen treatment. If you notice any of the symptoms related to these severe skin reactions described in section 4, stop using tamoxifen and seek medical attention immediately.
- If you have a history of hereditary angioedema, as tamoxifen may cause or worsen the symptoms of hereditary angioedema. If you experience symptoms such as swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing, contact a doctor immediately.
Other Medicines and Tamoxifen Cinfa
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
In particular, you should inform your doctor if you are taking anticoagulants such as warfarin (to prevent blood clots), paroxetine, fluoxetine (antidepressants), bupropion (antidepressant or used to quit smoking), quinidine (used to treat cardiac arrhythmia), or cinacalcet (for the treatment of parathyroid disorders).
Tamoxifen Cinfa should not be used with aromatase inhibitors such as anastrozole, letrozole, or exemestane.
Pregnancy, Breast-feeding, and Fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant or potentially pregnant women and breast-feeding mothers should not use this medicine during the two months following treatment cessation.
Do not take tamoxifen if you are breast-feeding, unless your doctor has analyzed the risks and benefits involved. It is not known whether tamoxifen passes into human milk.
Children and Adolescents
Tamoxifen should not be administered to children/adolescents, as its safety and efficacy in this age group have not been established.
Driving and Using Machines
This medicine is unlikely to affect your ability to drive or use machines.
Tamoxifen Cinfa contains Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".
3. How to take Tamoxifen Cinfa
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Recommended Dose for Adults
- The recommended dose is 20 mg to 40 mg daily.
- Normally, this medicine is taken once or twice a day.
Method of Administration
- Swallow the tablets whole with water.
- Try to take the tablet at the same time every day.
- Do not stop taking your tablets even if you feel well, unless your doctor tells you to.
If you take more Tamoxifen Cinfa than you should
If you take more tamoxifen than you should, contact a doctor or the nearest hospital immediately.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.
If you forget to take Tamoxifen Cinfa
Do not take a double dose to make up for forgotten doses.
If you forget a dose, take it as soon as you remember.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you stop taking Tamoxifen
Your doctor will tell you how long to take tamoxifen. Do not stop treatment before your doctor tells you to.
4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very Common Side Effects(may affect more than 1 in 10 people)
- Vascular disorders: Hot flushes.
Common Side Effects(may affect up to 1 in 10 people)
- Vascular disorders: Sudden weakness or paralysis of the arms or legs, sudden difficulty speaking, walking, holding things, or thinking (any of these may occur due to decreased blood flow to the brain and these symptoms may be a sign of a stroke), blockage of blood vessels.
- Reproductive system and breast disorders: Vaginal bleeding, vaginal discharge, itching around the vagina, endometrial changes (inside the uterus), menstrual irregularities.
- Gastrointestinal disorders: Gastrointestinal upset.
- Skin and subcutaneous tissue disorders: Hair loss, rash.
- Nervous system disorders: Headache, dizziness.
- General disorders: Symptoms related to your disease, fluid retention.
- Musculoskeletal and connective tissue disorders: Leg cramps.
Uncommon Side Effects(may affect up to 1 in 100 people)
- Eye disorders: Cataracts, changes in the retina.
- Reproductive system and breast disorders: Uterine fibroids, endometrial tumour (inside the uterus).
- General disorders: Hypersensitivity reactions.
- Investigations: Decreased platelet count, decreased white blood cell count, decreased neutrophil count, anaemia, changes in liver enzymes, increased blood fat levels.
Rare Side Effects(may affect up to 1 in 1,000 people)
- Eye disorders: Changes in the cornea, optic nerve disorders, optic nerve inflammation, and in a small number of cases, loss of vision (caused by optic nerve disorder/inflammation).
- Reproductive system and breast disorders: Uterine tumour (uterus), disorders of the tissue inside the uterus, ovarian cysts.
- Gastrointestinal disorders: Pancreatitis.
- Hepatobiliary disorders: Fatty liver, bile flow stoppage, hepatitis.
- Investigations: Elevated blood calcium levels.
Very Rare Side Effects(may affect up to 1 in 10,000 people)
- Respiratory, thoracic, and mediastinal disorders: Inflammation of the lung area.
- Skin and subcutaneous tissue disorders: Severe skin reactions, with lesions, ulcers, or blisters.
Stop taking this medicine and contact your doctor immediatelyin any of the following situations:
- If you experience symptoms of a blood clot such as swelling in the calf or leg, chest pain, shortness of breath, or sudden weakness.
- Red patches, target-like or circular, on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome, toxic epidermal necrolysis] – these side effects are rare.
- Swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema). Tamoxifen may cause or worsen the symptoms of hereditary angioedema.
Reporting of Side Effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Tamoxifen Cinfa
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the Pack and Further Information
Composition of Tamoxifen Cinfa
The active substance is tamoxifen. Each tablet contains 10 mg of tamoxifen (as citrate).
The other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A) (potato), povidone, magnesium stearate, and anhydrous colloidal silica.
Appearance of the Product and Pack Size
Tamoxifen Cinfa is presented as white, cylindrical, biconvex tablets with one side scored and marked with "10" and the other side plain.
It is available in PVC/ALU blister packs. Each pack contains 30 or 100 tablets.
Marketing Authorisation Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Or
Laboratorios Cinfa, S.A.
Avda. Roncesvalles, s/n - Olloqui (Navarra) Spain
Or
Cyndea Pharma
Polígono Industrial Emiliano Revilla Sanz,
Av. Ágreda, 31, 42110 Ólvega, Soria. Spain.
Date of Last Revision of this Leaflet:December 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63754/P_63754.html
QR code to: https://cima.aemps.es/cima/dochtml/p/63754/P_63754.html
- Country of registration
- Average pharmacy price8.43 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to TAMOXIFENE CINFA 10 mg TABLETSDosage form: TABLET, 20 mgActive substance: tamoxifenManufacturer: Laboratorios Cinfa S.A.Prescription requiredDosage form: TABLET, 20 mgActive substance: tamoxifenManufacturer: Teva Pharma S.L.U.Prescription requiredDosage form: TABLET, 10 mgActive substance: tamoxifenManufacturer: Laboratorios Tillomed Spain S.L.Prescription required
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